Enrollment complete in phase III EXPLORER CN study of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy

“Despite the challenges posed by the COVID-19 lockdowns in Shanghai and other cities in China, EXPLORER-CN rapidly enrolled patients,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. “We believe this reflects Chinese oHCM patients’ high demand for new therapies, physician and patient enthusiasm for the compelling data generated in global clinical trials of mavacamten, and LianBio’s strong clinical development execution capabilities on the ground in China. We thank the EXPLORER-CN participants and their families for their involvement in this important clinical study as we work to make mavacamten available to the world’s largest population of oHCM patients.”

EXPLORER-CN is a Phase III multicenter, double-blind, randomized, placebo-controlled registrational study designed to evaluate the safety and efficacy of mavacamten in Chinese patients with symptomatic oHCM . The primary endpoint is the change in Valsalva left ventricular outflow tract (LVOT) gradient from baseline to week 30. Eligible patients will continue in a long-term extension treatment period. More information about the EXPLORER-CN trial can be found on ClinicalTrials.gov (NCT05174416) or http://www.chinadrugtrials.org.cn/index.html (CTR20212890).

“We expect to report topline results in mid-2023 and, if positive, will use the data from EXPLORER-CN and our pharmacokinetics study in combination with the data generated in the global Phase III EXPLORER-HCM clinical trial to support a New Drug Application submission in China,” continued Dr. Wang. “This is a critically important step in the evolution of LianBio as we prepare to advance this potentially transformative therapy towards regulatory approval in China.”